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This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.
Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.
Arm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy | Experimental | Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first. |
|
| placebo + carboplatin/cisplatin-etoposide + radiotherapy | Placebo Comparator | Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX10 | Drug | Serplulimab is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. 300mg Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS, assessed by the Blinded Independent Central Review (BICR) as per RECIST v1.1 | up to approximately 24months |
| Overall survival (OS) | the time from randomization to death due to any cause | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | PFS, assessed by the investigator as per RECIST v1.1 | up to approximately 24months |
| Objective response rate (ORR) | ORR, assessed by the BICR and investigator as per RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinming Yu, MD | Shandong Cancer Hospital & Institute-department | Principal Investigator |
| Ying Cheng | Jilin Provincial Tumor Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OPN-Glendale | Arcadia | California | 91007 | United States | ||
| OPN-Los Alamitos |
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|
| carboplatin/cisplatin-etoposide | Drug | Etoposide: 100 mg/m2, IV, on Days 1, 2, and 3 of each cycle. Carboplatin: AUC = 5, IV, on Day 1 of each cycle up to a dose of 750 mg. investigator's choice. Cisplatin: 75mg/m2, IV, on Days 1 of each cycle. investigator's choice. |
|
| Thoracic radiotherapy | Radiation | Standard Thoracic Radiotherapy |
|
| Placebo | Drug | Placebo Q3W |
|
| Prophylactic Cranial Irradiation (PCI) | Radiation | PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment. |
|
| up to approximately 24months |
| Duration of remission (DOR) | DOR, assessed by the BICR and investigator as per RECIST 1.1 | up to approximately 24months |
| Los Alamitos |
| California |
| 90720 |
| United States |
| Southern California Permanente Group | Los Angeles | California | 90034 | United States |
| Emad Ibrahim, MD, Inc | Redlands | California | 92373 | United States |
| Providence Medical Foundation | Santa Rosa | California | 95403 | United States |
| Lutheran Medical Center - Cancer Centers of Colorado | Golden | Colorado | 80401 | United States |
| Eastern Connecticut Hematology & Oncology Associates | Norwich | Connecticut | 06360 | United States |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32257 | United States |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763 | United States |
| Advent Health Orlando | Orlando | Florida | 32804 | United States |
| Napa Research | Pompano Beach | Florida | 33064 | United States |
| Kansas University Mediacal Center | Fairway | Kansas | 66205 | United States |
| Pontchartrain Cancer Center | Covington | Louisiana | 70433 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Health Partners | Bloomington | Minnesota | 55425 | United States |
| Renown Health | Reno | Nevada | 89502 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| New York City Health+HospitalsCorporation Elmhurst Hospital Center | Elmhurst | New York | 11373 | United States |
| Northwell Health | Queens | New York | 11040 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Cleveland Clinic Mercy Hospital | Canton | Ohio | 44708 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| Tricounty Hematology and Oncology Associates | Massillon | Ohio | 44646 | United States |
| Kaiser Permanente Northwest | Portland | Oregon | 97229 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Millennium Research & Clinical Development | Houston | Texas | 77090 | United States |
| Pro Research Tools, INC DBA Lumi Research | Kingwood | Texas | 77339 | United States |
| The University of Texas - Hope Cancer Center | Tyler | Texas | 75701 | United States |
| Innova Schar Cancer Insitute | Fairfax | Virginia | 22031 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| Klinikum Klagenfurt am Worthersee | Klagenfurt | 9020 | Austria |
| Klinikum Klagenfurt am Wörthersee | Klagenfurt | 9020 | Austria |
| Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie, c/o Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie | Vienna | 1210 | Austria |
| Karl Landsteiner Institute for Lung Research and Pneumological Oncology, c/o Klinik Floridsdorf Department for Inner Medicine und Pneumology | Vienna | 1210 | Austria |
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233099 | China |
| Anhui Chest Hospital | Hefei | Anhui | 230031 | China |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| The First Affiliated Hospital of Chongqing Medical | Chongqing | Chongqing Municipality | 400016 | China |
| Chongqing University Cancer Hospital | Chongqing | Chongqing Municipality | 400030 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350011 | China |
| The First Affiliated Hospital of Guangdong Pharmaceutical University | Guangzhou | Guangdong | 510000 | China |
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510030 | China |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
| The Second Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | 541100 | China |
| Guangxi Medical University Cancer Hospital | Nanning | Guangxi | 530021 | China |
| Gungzhouyikedaxuefushuzhongliuyiyuan | Guangzhou | Guangzhou | 510095 | China |
| Affiliated Hospital of Hebei University | Baoding | Hebei | 071000 | China |
| Cangzhou People's Hospital | Cangzhou | Hebei | 061019 | China |
| Tangshan People's Hospital | Tangshan | Hebei | 063001 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Jiamusi Cancer Hospital | Jiamusi | Heilongjiang | 154007 | China |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | 471000 | China |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | 453100 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Hong Kong United Oncology Centre | Hong Kong | Hong Kong | 999077 | China |
| Queen Elizabeth Hospital | Hong Kong | Hong Kong | 999077 | China |
| Queen Mary Hospital | Hong Kong | Hong Kong | 999077 | China |
| TaiHe Hospital Affiliated Hospital of Hubei University of Medicine | Shiyan | Hubei | 442000 | China |
| Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology | Wuhan | Hubei | 430030 | China |
| Zhongnan hospital of wuhan university | Wuhan | Hubei | 430071 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| The First People's Hospital Of Changde City | Changde | Hunan | 415000 | China |
| The Second Xiangya Hospita | Changsha | Hunan | 410008 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Xiangya Hospital Central South University | Changsha | Hunan | 410013 | China |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | 221000 | China |
| Northern Jiangsu people's Hospital | Yangzhou | Jiangsu | 210008 | China |
| First Affiliated Hospital of Gannan Medical University | Ganzhou | Jiangxi | 341001 | China |
| Ganzhou Cancer Hospital | Ganzhou | Jiangxi | 341005 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130000 | China |
| Liaoning Cancer Hospital & Institute | Shenyang | Liaoning | 110042 | China |
| Shenyang The Tenth People's Hospital | Shenyang | Liaoning | 110044 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| Linyi Tumor Hospital | Linyi | Shandong | 276002 | China |
| Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266031 | China |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Wenzhou University Hospital | Wenzhou | Shanghai Municipality | 200032 | China |
| Baoji Central Hospital | Baoji | Shanxi | 721008 | China |
| Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi | 030013 | China |
| First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | 710061 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| The Second People's Hospital Of Yibin | Sichuan | Yibin | 644000 | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | 650118 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
| Yuhang Branch of the First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310005 | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| Taizhou Hospital of Zhejiang Province | Taizhou | Zhejiang | 317000 | China |
| The 1st Affiliated Hospital of WMU | Wenzhou | Zhejiang | 325000 | China |
| University Hospital Brno (Clinic For Lung Diseases and Tuberculosis) | Brno | 625 00 | Czechia |
| University Hospital Brno | Brno | 625 00 | Czechia |
| University Hospital Olomouc (Oncology Clinic) | Olomouc | 775 20 | Czechia |
| University Hospital Ostrava (oncology department) | Ostrava-Poruba | 570852 | Czechia |
| University Hospital Ostrava | Ostrava-Poruba | Czechia |
| Nemocnice AGEL Ostrava-Vítkovice | Ostrava-Vitkovice | 703 00 | Czechia |
| Nemocnice AGEL Ostrava-Vítkovice | Ostrava-Vítkovice | 703 00 | Czechia |
| General University hospital in Prague (Oncology department) | Prague | 128 08 | Czechia |
| University Hospital Motol | Prague | 150 06 | Czechia |
| University Hospital Motol (Pneumology Clinic 2.LF UK and FN Motol) | Prague | Czechia |
| Kliniken der Stadt Cologne GmbH | Cologne | 51109 | Germany |
| University hospital Schleswig-Holstein | Travemünde | 23538 | Germany |
| "Sotiria" Thoracic Diseases General Hospital of Athens | Athens | 115 27 | Greece |
| General Hospital of Athens "Alexandra" | Athens | 11528 | Greece |
| Fejer County Szent Gyorgy University Teaching Hospital | Székesfehérvár | 8000 | Hungary |
| Pulmonary Institute of Torokbalint | Törökbálint | 2045 | Hungary |
| Riga East University Hospital, Latvian Oncology Center | Riga | LV 1079 | Latvia |
| Clinic of Oncology, Pauls Stradins Clinical university hospital | Riga | LV-1002 | Latvia |
| Hospital St. Jansdal | Harderwijk | 3844 | Netherlands |
| Isala Hospital | Zwolle | 8025 | Netherlands |
| MedPoloniaSp. z o.o. | Poznan | 60-693 | Poland |
| Lung and Chest Cancer Clinic, National Institute of Oncology | Warsaw | 02-781 | Poland |
| Hospital Universitario de Badajoz | Badajoz | 6006 | Spain |
| Hospital German Trias i Pujol/ ICO Badalona | Badalona | 8916 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 8025 | Spain |
| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario Puerta de Hierro | Madrid | 2822 | Spain |
| Hospital Quironsalud Sagrado Corazón | Seville | 41013 | Spain |
| Hospital Marques de Valdecilla | Valdecilla | 39008 | Spain |
| University Hospital La Fe | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| C075609 | PE regimen |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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